What are the recommended guidelines for disinfection and reprocessing of medical equipment in a healthcare setting?

Disinfection and Reprocessing Guidelines for Medical Equipment in Healthcare Settings

Core Recommendation

Medical equipment must be classified according to the Spaulding system and reprocessed accordingly: critical items require sterilization, semi-critical items require high-level disinfection (HLD), and non-critical items require low-level disinfection, with meticulous cleaning always preceding disinfection or sterilization. 1

Equipment Classification and Required Processing Level

Critical Items

• Definition: Devices that enter sterile tissue, vascular spaces, or penetrate mucosal barriers 1
• Required processing: Sterilization mandatory 1, 2, 3
• Examples: Surgical instruments, biopsy forceps, injection needles 1
• Key point: Single-use critical items cannot be reused; reusable items must undergo sterilization per manufacturer's instructions for use (IFU) 1

Semi-Critical Items

• Definition: Devices contacting mucous membranes or non-intact skin without penetrating sterile tissue 1
• Required processing: Minimum of high-level disinfection 1, 3
• Examples: Gastrointestinal endoscopes, bronchoscopes, respiratory therapy equipment 1
• Critical consideration: Endoscopes are classified as semi-critical per Spaulding, though high-risk endoscopes (duodenoscopes, linear ultrasound endoscopes) should be considered for reclassification to critical items requiring sterilization 1

Non-Critical Items

• Definition: Devices contacting intact skin only 1
• Required processing: Low-level disinfection or cleaning 1, 4
• Examples: Blood pressure cuffs, environmental surfaces 1, 4

Endoscope Reprocessing Protocol (Most Complex Semi-Critical Items)

Immediate Point-of-Use Treatment

• Flush all channels with clean water immediately after procedure completion 1
• Wipe external surfaces with enzymatic detergent 1
• Transport in closed container to minimize exposure 1

Manual Cleaning (Essential First Step)

• Perform leak testing before immersion 1
• Brush all accessible channels with appropriate brushes 1
• Flush all channels with enzymatic detergent 1
• Visual inspection must occur at point-of-use and immediately after manual cleaning 1
• Use lighted magnification for complex components like elevator mechanisms 1

High-Level Disinfection or Sterilization

• Automated endoscope reprocessor (AER) or manual HLD is acceptable 1
• For high-risk endoscopes: Consider liquid chemical sterilization with peracetic acid (PAA) as the most practical sterilization option 1
• Ethylene oxide sterilization is effective but has long turnaround times and toxicity concerns 1
• Hydrogen peroxide vapor sterilization is NOT recommended for flexible endoscopes due to inability to penetrate long, narrow channels 1

Drying and Storage

• Forced-air drying of all channels is essential 1
• Hang vertically with caps removed during storage 1
• Storage time for high-risk endoscopes: Less than 3 days recommended 1
• Auxiliary water channel: Must remain unlocked with inlet cap removed during storage 1

Respiratory Therapy Equipment

Nebulizers and Ventilator Circuits

• Small-volume nebulizers: Sterilize or HLD between patients; rinse with sterile water and air-dry between treatments 1
• Large-volume nebulizers: Sterilize or HLD every 24 hours on same patient 1
• Ventilator circuits: Clean and sterilize or HLD between patients 1
• Do NOT routinely sterilize internal machinery of ventilators or anesthesia equipment 1

Resuscitation Equipment

• Hand-powered resuscitation bags: Sterilize or HLD between patients 1
• Respirometers and oxygen sensors: Sterilize or HLD between patients 1

Quality Control and Documentation Requirements

Mandatory Documentation

• Each disinfection cycle: Record minimum effective concentration (MEC) of disinfectant before use 1
• Each procedure: Document procedure time, point-of-use treatment completion time, storage time, patient identifiers 1
• Equipment maintenance: Track preventive maintenance and repairs per manufacturer's IFU 1
• Tracking is essential for responding to disinfection failures and product recalls 1

Cleaning Verification

• Regular testing using ATP, residual protein, hemoglobin, or carbohydrate assays 1
• Borescope inspection after reprocessing to detect residual contamination or channel damage 1
• Monthly microbial culture surveillance of endoscopes recommended 1

Environmental Considerations

Room Requirements for High-Risk Procedures

• Negative pressure rooms with minimum 12 air changes per hour (ACH) preferred 1
• Alternative: Natural ventilation with airflow of at least 160 L/s 1
• Allow adequate time (minimum 30 minutes) between procedures for air clearance 1

Workflow Design

• Implement one-way flow from contaminated to clean areas 1
• Color-coded zones: Red (contaminated), yellow (transition), green (clean) 1
• Separate reprocessing room from procedure areas 1

Personal Protective Equipment for Reprocessing Staff

Personnel performing reprocessing must wear: 1

• Eye protection
• Respiratory protection (FP2/N95 mask for high-risk situations)
• Long-sleeved gown
• Double gloves

Common Pitfalls and Special Considerations

Delayed Reprocessing

• If cleaning delayed >1 hour after point-of-use treatment: Perform enhanced protocol with leak testing, pre-soaking in enzymatic detergent, channel flushing, then complete manual cleaning before HLD 1

Simethicone Use

• Use lowest concentration (0.5% v/v; 10 mg/100 mL) and smallest volume when administered through endoscope 1
• Standard reprocessing may not effectively remove simethicone from working channels 1

Water Bottle and Auxiliary Channels

• Manual cleaning followed by HLD or steam sterilization required 1
• Inject disinfectant into water bottle tube with cleaning cap attached 1
• Dry thoroughly with forced air before storage 1

Chemical Disinfectant Selection

• Glutaraldehyde, hydrogen peroxide, peracetic acid, sodium hypochlorite are acceptable HLD agents 2, 5
• Peracetic acid is more powerful and faster-acting than glutaraldehyde or orthophthalaldehyde for sterilization 1
• Record MEC before each use to ensure efficacy 1

Adherence to Manufacturer Instructions

Always follow manufacturer's IFU for specific devices, as deviations can compromise patient safety and void warranties 1, 2, 3, 5, 6. When guidelines conflict with IFU, prioritize the more stringent requirement to minimize infection risk.